Hanall Biopharma said its Chinese partner, Harbour BioMed, has received approval from China's National Medical Products Administration (NMPA) to conduct a phase 2 clinical trial of HL161 for chronic inflammatory demyelinating polyneuropathy.
Harbour BioMed signed an agreement with Hanall Biopharma in 2017 and acquired the rights to develop and sell HL161 in China.
Hanall Biopharma's local partner has been developing the drug for treating myasthenia gravis, thyroid ophthalmopathy, thrombocytopenia, and optic neuromyelitis. It now plans to add chronic inflammatory demyelinating polyneuropathy to the list of diseases with high unmet medical needs.
Chronic inflammatory demyelinating polyneuropathy is a disorder characterized by progressive weakness in the muscle and impaired sensory function. Although steroid and immunoglobulin therapies are used for patients, the demand for effective treatments with fewer side effects is still high.
Intravenous immunoglobulin is a treatment that relieves symptoms by administering large amounts of antibodies collected from other people's serum.
Earlier, Hanall Biopharma's U.S. partner Immunovant began developing HL161 for treating myasthenia gravis, thyroid ophthalmopathy, and warm antibody hemolytic anemia. Immunovant is preparing for clinical trials of HL161 for five diseases by adding two indications in the following year.
Immunovant CEO Pete Salzmann said, “We plan to resume hemolytic anemia phase 2 trials with the phase 3 study of myasthenia gravis at the end of 2021 or early next year, and will begin two to three additional clinical trials within a year.”
The recent Chinese approval added chronic inflammatory demyelinating polyneuropathy to the existing targeted diseases, including myasthenia gravis, thyroid ophthalmopathy, warm antibody hemolytic anemia, thrombocytopenia, and optic neuromyelitis, in China and the U.S., according to HanAll Biopharma.
"Due to the side effects of steroids and the limited accessibility of immunoglobulin therapies, there is an urgent need for effective and new therapeutic agents for autoimmune diseases," Harbour Biomed CEO Jingsong Wang said. "The novel mechanism of HL161 will make it a safe and effective therapeutic option."